The abstract of preliminary data from a Phase 1a trial of HF1K16, which targets myeloid-derived suppressor cells (MDSCs), is published online at the 2023 ASCO Annual Meeting in Chicago, IL

HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, announced today the publication of an abstract including preliminary data from a Phase 1a clinical trial of HF1K16 in refractory metastatic cancer patients. It was published online at the American Society of Clinical Oncology (ASCO) Annual Meeting. HF1K16 is a drug encapsulated immune modulating liposome containing all-trans retinoic acid. The ASCO meeting is June 2 – 6, 2023, at the McCormick Place, Chicago, IL.

The HighField Bio abstract is titled “Modulating MDSCs by HF1K16: a monotherapy Phase 1a study examining safety and preliminary efficacy in refractory and metastatic cancer patients.”

“We are excited about the preliminary data,” said Yuhong Xu, CEO of HighField Bio. “The data show HF1K16 is well tolerated and patients have experienced significant progression-free survival.” The abstract also reports that of the 11 patients treated, three who suffer from recurrent and refractory glioma continued to experience progression-free survival. One patient has been on treatment for 348 days. The other two are 94 days and 52 days with progression-free survival from the start of treatment.

Dr. Xu noted, “Four patients reached stable disease diagnosis based on RECIST 1.1 criteria. One patient experienced a reduction in size of the main brain lesion from 70mm to 23.7mm.”

HF1K16 is a unique liposome construct of ATRA, a small molecule metabolite of vitamin A, administered by infusion, and travels through the blood stream and infiltrates the tumor microenvironment. ATRA is released and initiates the maturation of Myeloid-Derived Suppressor Cells (MDSCs).

MDSCs are immature myeloid cells which have not differentiated. ATRA promotes the maturation and differentiation of MDSCs into functional cells, such as dendritic cells, which then summon T cells to attack the cancer.

The preliminary data reported at ASCO is from an ongoing Phase 1a trial in China with patients suffering from a variety of refractory metastatic cancers. Based on the positive findings related to glioma, HighField Bio expects to begin a Phase 1b/2 trial in China for patients with refractory glioma in the next few weeks.

About HighField Biopharmaceuticals

HighField Bio is a clinical stage immuno-oncology company focused on novel applications of liposome constructs to disrupt existing immuno-oncology technologies. The company has a research and development center and a GMP-compliant production facility. HighField Bio’s lead clinical development program is HF1K16, a drug encapsulated immune modulating liposome containing all-trans retinoic acid targeting myeloid-derived suppressor cells for treatment of solid tumors. For more information visit https://highfield.bio.

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